Chronic Heart FailureNCT01139086
Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure (CHF)
An observational study of Chronic Heart Failure and Coronary Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart failure (CHF). Recent studies suggested that peripheral impairment was the major cause of clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular smooth muscle dysfunction. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Heart Failure, Coronary Disease, Dilated Cardiomyopathy
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- May 2010to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Chronic Heart Failure Coronary Disease Dilated Cardiomyopathy Control group without diagnosis of any heart disease
Who may be able to join
- Age 40-75 years
- Chronic heart failure: ejection fraction<40% and at stable condition
- Coronary Disease and dilated cardiomyopathy without heart failure
- Control group without diagnosis of any heart disease
Who cannot join
- Clinical diagnosis of neuromusculoskeletal , pulmonary, or other systemic diseases that may affect the testing of the study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Ying-Tai Wu, Ph. D, 886-2-33668129, ytw@ntu.edu.tw
About this study
Official title: Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure
Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart failure (CHF). Recent studies suggested that peripheral impairment was the major cause of clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular smooth muscle dysfunction. It results in increased peripheral resistance that may influence limb blood flow, muscle fitness and activities of daily.The purposes of this study are
- to compare muscular strength, endurance, and perfusion of quadriceps between CHF patients and healthy controls by isokinetic test and near-infrared spectroscopy (NIRS) and difference in activities of daily living
- to compare endothelium function between CHF patients and healthy control subjects
- the relationship between endothelium function, muscular strength, endurance, perfusion, and metabolism of quadriceps.
- Keywords
- chronic heart failure, isokinetic test, near-infrared spectroscopy, laser Doppler flowmetry, endothelial function
- Medical subject headings
- Coronary Disease, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular disease | Diagnosis of cardiomyopathy or ischemic heart disease without heart failure | |
| Chronic heart failure | Diagnosis of cardiomyopathy or ischemic heart disease LVEF <40% | |
| Control | Age and body built matched with chronic heart failure group |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength and endurance
Measured by biodex
Measured: baseline
Secondary outcomes (6)
skeletal muscle oxygenation response
Measured by near-infrared spectroscopy
Measured: baseline
Walking distance in 6-minute walking test
walking distance (m)
Measured: baseline
laser Doppler flowmetry combine iontophoresis
To measure the blood flux (PU) response to Ach (endothelial-dependent agent) and SNP (endothelial-independent agent)
Measured: baseline
sit-to-stand test
Measured times in 1 minute
Measured: baseline
questionnaire (functional activity and quality of life)
Measured: baseline
Analysis of venous blood sample
By standard venipuncture
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionMay 2011 (estimated)
- Study completionMay 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ying-Tai Wu, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139086
- Sponsor's protocol ID
- 201003050R
- Status last verified
- Jun 2010
- First submitted
- 7 Jun 2010
- Last updated
- 8 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endothelial Function, Muscular Fitness and Metabolism in Functional Activity in Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT01139086
- Acronym / sponsor ID
- 201003050R
- Keywords
- chronic heart failure, isokinetic test, near-infrared spectroscopy, laser Doppler flowmetry, endothelial function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 8 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shortness of breath, fatigue, and exercise intolerance are clinical symptoms of chronic heart failure (CHF). Recent studies suggested that peripheral impairment was the major cause of clinical symptoms, and mechanism may be related to neuroendocrine impairment and vascular smooth muscle dysfunction. It results in increased peripheral resistance that may influence limb blood flow, muscle fitness and activities of daily.The purposes of this study are
- to compare muscular strength, endurance, and perfusion of quadriceps between CHF patients and healthy controls by isokinetic test and near-infrared spectroscopy (NIRS) and difference in activities of daily living
- to compare endothelium function between CHF patients and healthy control subjects
- the relationship between endothelium function, muscular strength, endurance, perfusion, and metabolism of quadriceps.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular disease | – | –Diagnosis of cardiomyopathy or ischemic heart disease without heart failure |
| Chronic heart failure | – | –Diagnosis of cardiomyopathy or ischemic heart disease LVEF <40% |
| Control | – | –Age and body built matched with chronic heart failure group |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Heart Failure Coronary Disease Dilated Cardiomyopathy Control group without diagnosis of any heart disease
Key inclusion criteria (4 listed)
- Age 40-75 years
- Chronic heart failure: ejection fraction<40% and at stable condition
- Coronary Disease and dilated cardiomyopathy without heart failure
- Control group without diagnosis of any heart disease
Key exclusion criteria (1 listed)
- Clinical diagnosis of neuromusculoskeletal , pulmonary, or other systemic diseases that may affect the testing of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
muscle strength and endurance
Time frame: baseline
Measured by biodex
6 secondary outcomes
skeletal muscle oxygenation response
Time frame: baseline
Walking distance in 6-minute walking test
Time frame: baseline
laser Doppler flowmetry combine iontophoresis
Time frame: baseline
sit-to-stand test
Time frame: baseline
questionnaire (functional activity and quality of life)
Time frame: baseline
Analysis of venous blood sample
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying-Tai Wu, Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure and Coronary Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-Tai Wu, Ph.D (+886-2-33668129, ytw@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength and endurance (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2010.